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Additional information about the drug Diclofenac

Diclofenac (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and as an analgesic reducing pain in certain conditions. It is supplied as or contained in medications under a variety of trade names.
The primary mechanism responsible for its anti-inflammatory, antipyretic, and analgesic action is thought to be inhibition of prostaglandin synthesis by inhibition of cycloxygenase-2 (COX-2). Diclofenac inhibits COX-2 with 20-fold more potency than COX-1 and is said to have a lower incidence of gastrointestinal complaints than COX-1 inhibitors such as aspirin. Some evidence indicates it inhibits the lipoxygenase pathways which are related to inflammation,, and possibly phospholipase A2, as well as possibly phase inhibition (blockage) of voltage-dependent sodium channels, blockage of acid-sensing ion channels (ASICs) and positive allosteric modulation of KCNQ- and BK- potassium channels (related to hyperpolarization of the cell membrane). It also appears to exhibit bacteriostatic activity. Diclofenac lasts for around 6–8 hours in the body, possibly as it persists for over 11 hours in synovial fluids.
The name “diclofenac” derives from its chemical name: 2-(2,6- dic h lo ranilino) phen yl ac etic acid. Diclofenac was first synthesized by Alfred Sallmann and Rudolf Pfister and introduced as Voltaren by Ciba-Geigy (now Novartis ) in 1973, now by Glaxo SmithKline.
Use of diclofenac for animals is controversial due to toxicity when eaten by scavenging birds that eat dead animals; the drug has been banned for veterinary use in many countries.
Contents
1 Medical uses
1.1 Pain
2 Contraindications
3 Adverse effects
3.1 Cardiac
3.2 Gastrointestinal
3.3 Hepatic
3.4 Renal
3.5 Mental health
4 Mechanism of action
5 Ecological effects
6 Formulations and trade names
7 References
8 External links
Medical uses
Diclofenac is used to treat pain, inflammatory disorders, and dysmenorrhea.
Pain
Inflammatory disorders may include musculoskeletal complaints, especially arthritis, rheumatoid arthritis, polymyositis, dermatomyositis, osteoarthritis, dental pain, temporomandibular joint (TMJ) pain, spondylarthritis, ankylosing spondylitis, gout attacks, and is effective against menstrual pain and endometriosis.
Diclofenac is also available in topical forms and has been found to be useful for osteoarthritis but not other types of long-term musculoskeletal pain.
It may also help with actinic keratosis, and acute pain caused by minor strains, sprains, and contusions (bruises).
In many countries,
Diclofenac is often used to treat chronic pain associated with cancer, in particular if inflammation is also present (Step I of the World Health Organization (WHO) scheme for treatment of chronic pain). Diclofenac can be combined with opioids if needed such as a fixed combination of diclofenac and codeine.
Voltaren (diclofenac) 50 mg enteric coated tablets
Arthrotec (diclofenac and misoprostol ) 50 mg tablets
Dyloject (diclofenac) 2 ml for IV and IM administration
Sintofarm (diclofenac) for suppository administration
Contraindications
Hypersensitivity against diclofenac
History of allergic reactions ( bronchospasm, shock, rhinitis, urticaria ) following the use of other NSAIDs such as aspirin
Third-trimester pregnancy
Active stomach and/or duodenal ulceration or gastrointestinal bleeding
Inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
Severe insufficiency of the heart (NYHA III/IV)
Pain management in the setting of coronary artery bypass graft (CABG) surgery
Severe liver insufficiency (Child-Pugh Class C)
Severe renal insufficiency (creatinine clearance <30 ml/min)
Caution in patients with pre-existing hepatic porphyria, as diclofenac may trigger attacks
Caution in patients with severe, active bleeding such as cerebral hemorrhage
NSAIDs in general should be avoided during dengue fever, as it induces (often severe) capillary leakage and subsequent heart failure.
Caution in patients with fluid retention or heart failure
Can lead to onset of new hypertension or worsening of pre-existing hypertension
Can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal
Adverse effects
See also: Nonsteroidal anti-inflammatory drug
Diclofenac consumption has been associated with significantly increased vascular and coronary risk in a study including coxib, diclofenac, ibuprofen and naproxen.
Cardiac
In 2013, a study funded by core grants from the UK Medical Research Council and the British Heart Foundations, and collaboration coordinated by the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) at the University of Oxford, UK; major vascular events were increased by about a third by diclofenac (rate ratio 1·41,95% CI 1·12–1·78; p=0·0036), chiefly due to an increase in major coronary events (1·70, 1·19–2·41; p=0·0032).
Following the identification of increased risks of heart attacks with the selective COX-2 inhibitor rofecoxib in 2004, attention has focused on all the other members of the NSAIDs group, including diclofenac. Research results are mixed, with a meta-analysis of papers and reports up to April 2006 suggesting a relative increased rate of heart disease of 1.63 compared to nonusers.
A subsequent large study of 74,838 Danish users of NSAIDs or coxibs found no additional cardiovascular risk from diclofenac use.
Another Danish study, at Aarhus University, has made use of the Danish health registry system’s data of over 1.3 million diclofenac users to show that subjects beginning use of it had a 50% increased 30-day risk for a composite outcome of Major adverse cardiovascular events (MACE) compared with individuals who didn’t initiate an NSAID or acetaminophen (95% confidence interval for incidence rate ratio, 1.4-1.7). The risk was also significantly elevated when compared with beginning other NSAIDs or acetaminophen: with those starting ibuprofen or acetaminophen, the MACE risk was elevated 20% in diclofenac initiators (95% CI, 1.1-1.3 for both). Initiating diclofenac was associated with 30% greater risk for MACE compared with initiating naproxen (95% CI, 1.1-1.5). In comparison with other NSAIDs, the short half-life of diclofenac means that a supratherapeutic plasma concentration of diclofenac soon after initiation achieves not just cyclooxygenase-2 (COX-2), but also COX-1 inhibition. However, after those high levels fall, patients taking diclofenac spend a substantial period of time with unopposed COX-2 inhibition, a state that is known to be prothrombotic, and also associated with blood pressure elevation, atherogenesis, and worsening of heart failure.
Diclofenac is similar in COX-2 selectivity to celecoxib.
Gastrointestinal
Gastrointestinal complaints are most often noted. The development of ulceration and/or bleeding requires immediate termination of treatment with diclofenac. Most patients receive a gastro-protective drug as prophylaxis during long-term treatment ( misoprostol, ranitidine 150 mg at bedtime or omeprazole 20 mg at bedtime).
Hepatic
Liver damage occurs infrequently, and is usually reversible. Hepatitis may occur rarely without any warning symptoms and may be fatal. Patients with osteoarthritis more often develop symptomatic liver disease than patients with rheumatoid arthritis. Liver function should be monitored regularly during long-term treatment. If used for the short-term treatment of pain or fever, diclofenac has not been found more hepatotoxic than other NSAIDs.
As of December 2009, Endo, Novartis, and the US FDA notified healthcare professionals to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.
Cases of drug-induced hepatotoxicity have been reported in the first month, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 week after initiating treatment with diclofenac.
Renal
NSAIDs “are associated with adverse renal
Studies in Pakistan showed diclofenac caused acute kidney failure in vultures when they ate the carcasses of animals that had recently been treated with it. Drug-sensitive species and individual humans are initially assumed to lack genes expressing specific drug detoxification enzymes.
Mental health
Mental health side effects have been reported. These symptoms are rare, but exist in significant enough numbers to include as potential side effects. These include depression, anxiety, irritability, nightmares, and psychotic reactions.
Mechanism of action
The primary mechanism responsible for its anti-inflammatory, antipyretic, and analgesic action is thought to be inhibition of prostaglandin synthesis by inhibition of the transiently expressed prostaglandin-endoperoxide synthase-2 (PGES-2) also known as cycloxygenase-2 (COX-2). It also appears to exhibit bacteriostatic activity by inhibiting bacterial DNA synthesis.
Inhibition of prostaglandin synthesis occurs systemically resulting in undesirable symptoms such as irritation of the gastric epithelium. and has, therefore, a somewhat lower incidence of gastrointestinal complaints than noted with aspirin which inhibits COX-1 to a greater extent.
The action of one single dose is much longer (6 to 8 hr) than the very short 1.2–2 hr half-life of the drug would indicate. This could be partly because it persists for over 11 hours in synovial fluids.
Diclofenac may also be a unique member of the NSAIDs. Some evidence indicates it inhibits the lipoxygenase pathways,
Marked differences exist among NSAIDs in their selective inhibition of the two subtypes of cyclooxygenase, COX-1 and COX-2.
Besides the COX-inhibition, a number of other molecular targets of diclofenac possibly contributing to its pain-relieving actions have recently been identified. These include:
Blockage of voltage-dependent sodium channels (after activation of the channel, diclofenac inhibits its reactivation also known as phase inhibition)
Blockage of acid-sensing ion channels (ASICs)
Positive allosteric modulation of KCNQ- and BK- potassium channels (diclofenac opens these channels, leading to hyperpolarization of the cell membrane)
Ecological effects
Main article: Indian vulture crisis
Use of diclofenac in animals has been reported to have led to a sharp decline in the vulture population in the Indian subcontinent – a 95% decline by 2003 It is more expensive than diclofenac, but the price is coming down as more pharmaceutical companies begin to manufacture it.
Steppe eagles have the same vulnerability to diclofenac as vultures and may also fall victim to it.
“The loss of tens of millions of vultures over the last decade has had major ecological consequences across the Indian Subcontinent that pose a potential threat to human health. In many places, populations of feral dogs ( Canis familiaris ) have increased sharply from the disappearance of Gyps vultures as the main scavenger of wild and domestic ungulate carcasses. Associated with the rise in dog numbers is an increased risk of rabies ”
The loss of vultures has had a social impact on the Indian Zoroastrian Parsi community, who traditionally use vultures to dispose of human corpses in Towers of Silence, but are now compelled to seek alternative methods of disposal.
Despite the vulture crisis, diclofenac remains available in other countries including many in Europe.
Formulations and trade names
Pennsaid is a minimally systemic prescription topical lotion formulation of 1.5% w/w diclofenac sodium, which is approved in the US, Canada and other countries for osteoarthritis of the knee.
Flector Patch, a minimally systemic topical patch formulation of diclofenac, is indicated for acute pain due to minor sprains, strains, and contusions. The patch has been approved in many other countries outside the US under different brand names.
Voltaren and Voltarol contain the sodium salt of diclofenac. In the United Kingdom, Voltarol can be supplied with either the sodium salt or the potassium salt, while Cataflam, sold in some other countries, is the potassium salt only. However, Voltarol Emulgel contains diclofenac diethylammonium, in which a 1.16% concentration is equivalent to a 1% concentration of the sodium salt. In 2016 Voltarol was one of the biggest selling branded over-the-counter medications sold in Great Britain, with sales of £39.3 million.
Diclofenac is available in stomach acid-resistant formulations (25 and 50 mg), fast-disintegrating oral formulations (25 and 50 mg), powder for oral solution (50 mg), slow- and controlled-release forms (75, 100 or 150 mg), suppositories (50 and 100 mg), and injectable forms (50 and 75 mg).
Diclofenac is also available over-the-counter in some countries: 12.5 mg diclofenac as potassium salt in Switzerland (Voltaren dolo), the Netherlands (Voltaren K), and preparations containing 25 mg diclofenac as the potassium salt in Germany (various trade names), New Zealand, Australia, Japan, (Voltaren Rapid), and Sweden (Voltaren T and Diclofenac T). Diclofenac as potassium salt can be found throughout the Middle East in 25 mg and 50 mg doses (Cataflam).
Solaraze (3% diclofenac sodium gel) is topically applied, twice a day for three months, to manage the skin condition known as actinic or solar keratosis.
Parazone-DP is a combination of diclofenac potassium and paracetamol, manufactured and supplied by Ozone Pharmaceuticals and Chemicals, Gujarat, India. It is sold in Uruguay alone or, in combination with orphenadrine to treat muscle spasms/pain due to injuries (Dicloflex Ion).
On 14 January 2015, diclofenac oral preparations were reclassified as prescription-only medicines in the UK. The topical preparations are still available without prescription.
Diclofenac formulations are available worldwide under many different trade names.

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